Study of DCC-3084 in Participants With Advanced Malignancies Driven by the Mitogen-Activated Protein Kinase (MAPK) Pathway

Study Purpose

This is a multicenter, Phase 1/2 clinical trial to evaluate DCC-3084 alone or in combination with other cancer therapies in participants with advanced cancers. Module A will enroll participants with advanced/metastatic solid tumors. Additional modules exploring other cancers may be added to the master protocol at a later date. Each module will be conducted in 2 parts: Part 1 (Dose Escalation) and Part 2 (Dose Expansion).

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

No
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

Interventional
Eligible Ages 18 Years and Over
Gender All
More Inclusion & Exclusion Criteria

Inclusion Criteria:

General Inclusion Criteria ModA Part 1 and 2:
  • - Able to take oral medication.
  • - If a female is of childbearing potential, must have a negative pregnancy test prior to enrollment and all participants agree to follow the contraception requirements.
  • - Adequate organ function and electrolytes.
  • - Eastern Cooperative Oncology Group Performance Status (ECOG-PS) of 0 to 1 at Screening.
  • - Has a life expectancy of more than 6 months.
  • - In addition to these general inclusion criteria, participants must meet all the module cohort-specific inclusion criteria.
Inclusion Criteria ModA Part 1 Cohort Specific:
  • - Pathologically confirmed diagnosis of solid cancer and documentation of Kirsten rat sarcoma (KRAS), Harvey rat sarcoma virus (HRAS), neuroblastoma ras viral oncogene homolog (NRAS), v-raf murine sarcoma viral oncogene homolog B1 (BRAF), v-raf murine sarcoma viral oncogene homolog C1(CRAF), and/or neurofibromatosis 1 (NF1) mutation.
  • - Have exhausted all available standard of care therapies that are known to provide benefit for the participant's condition, as judged by the Investigator.
Inclusion Criteria ModA Part 2 Cohort Specific:
  • - Documented BRAF gene mutation.
  • - Pathologically confirmed diagnosis with PD after at least one prior line of therapy in the advanced or metastatic setting.

Exclusion Criteria:

General Exclusion Criteria ModA Part 1 and 2:
  • - Prior treatment with certain BRAF dimer inhibitors.
  • - Female participant is pregnant or lactating.
  • - Received any prior or concurrent medications or therapies known to be prohibited with DCC-3084 within 14 days.
  • - Received any prior antitumor therapy or any investigational therapy within a specified timeframe prior to first dose of DCC-3084.
  • - Known allergy or hypersensitivity to any component of the study drug.
  • - Invasive malignancy within 2 years prior to the first dose of study drug other than the study indication or specific types of cancer treated with curative intent.
  • - Have not recovered from all clinically relevant toxicities from prior therapy.
  • - Impaired cardiac function.
  • - History of recent thrombotic or embolic events.
  • - Malabsorption syndrome or other illness that could affect oral absorption.
  • - Major surgery within 28 days of the first dose of study drug.
  • - In addition to the general exclusion criteria, participants will also be excluded based on the cohort-specific exclusion criteria.

Exclusion Criteria:

Module A Part 2 Cohort Specific: • Has known co-occurring mutation of KRAS, HRAS, NRAS, NF1, epidermal growth factor receptor, Phosphoinositide-3-kinase, catalytic, alpha polypeptide (PI3KCA), or Phosphatase and TENsin homolog deleted on chromosome 10 (PTEN)

Trial Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

NCT06287463
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

Phase 1/Phase 2
Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

Deciphera Pharmaceuticals, LLC
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

N/A
Principal Investigator Affiliation N/A
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

Industry
Overall Status Recruiting
Countries United States
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

Advanced Solid Tumor, RAF Mutation, RAS Mutation, NF1 Mutation, Non-Small Cell Lung Cancer, Pancreatic Ductal Adenocarcinoma, Melanoma, BRAF Gene Mutation, CRAF Gene Mutation, Castration-Resistant Prostate Cancer (CRPC)
Arms & Interventions

Arms

Experimental: DCC-3084 Module A Escalation Phase (ModA Part 1)

Participants will receive DCC-3084 in ModA Part 1, Escalation Phase.

Experimental: DCC-3084 Module A Expansion Phase (ModA Part 2)

Participants will receive DCC-3084 in ModA Part 2, Expansion Phase.

Interventions

Drug: - DCC-3084

Administered orally

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

Los Angeles 5368361, California 5332921

Status

Recruiting

Address

University of Southern California - Norris Comprehensive Cancer Center

Los Angeles 5368361, California 5332921, 90033

San Francisco 5391959, California 5332921

Status

Recruiting

Address

University of California San Francisco (UCSF) Helen Diller Family Comprehensive Cancer Center

San Francisco 5391959, California 5332921, 94158

SCRI HealthONE, Denver 5419384, Colorado 5417618

Status

Recruiting

Address

SCRI HealthONE

Denver 5419384, Colorado 5417618, 80218

SCRI Florida Cancer Specialists, Orlando 4167147, Florida 4155751

Status

Recruiting

Address

SCRI Florida Cancer Specialists

Orlando 4167147, Florida 4155751, 32827

Dana-Farber Cancer Institute, Boston 4930956, Massachusetts 6254926

Status

Recruiting

Address

Dana-Farber Cancer Institute

Boston 4930956, Massachusetts 6254926, 02215

Roswell Park Comprehensive Cancer Center, Buffalo 5110629, New York 5128638

Status

Recruiting

Address

Roswell Park Comprehensive Cancer Center

Buffalo 5110629, New York 5128638, 14263

SCRI Oncology Partners, Nashville 4644585, Tennessee 4662168

Status

Recruiting

Address

SCRI Oncology Partners

Nashville 4644585, Tennessee 4662168, 37203

NEXT Oncology, San Antonio 4726206, Texas 4736286

Status

Recruiting

Address

NEXT Oncology

San Antonio 4726206, Texas 4736286, 78229

NEXT Oncology Virginia, Fairfax 4758023, Virginia 6254928

Status

Recruiting

Address

NEXT Oncology Virginia

Fairfax 4758023, Virginia 6254928, 22031

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